Alpha-Tec Systems Inc is a growing medical device company located in Vancouver, WA. We are seeking a full-time Process Engineer who will establish and maintain appropriate quality system elements consistent with GLP, cGMP, internal, customer and/or ISO requirements. The selected candidate will actively contribute to data collection, trend analysis, investigation and improvements to processes, products and systems.
Primary Duties:
Design, install and commission new production equipment, monitor modifications and upgrades, and troubleshoot existing processes.
Responsible for qualification, calibration, maintenance and repair of instruments and equipment in compliance with internal procedures, cGMP regulations and ISO standards.
Write and execute IQ/OQ/PQ protocols and reports for equipment/instrumentation.
Review and approve qualification documents.
Assure the development and utilization of equipment calibration and preventative maintenance systems.
Ensure equipment is in compliance with calibration, maintenance, monitoring, validation and revalidation requirements.
Experience required for this Position:
Background in qualification, calibration and maintenance.
Must be able to interpret diagrams, blueprints, sketches and handwritten instructions.
Experience in filing, tracking and updating daily maintenance records.
Experience with Microsoft based applications and general knowledge of PC functions.
Proficient in Solid Works.
Experience with working with regulatory agencies and/or ISO.
Additional requirements
Organized
Able to handle multiple projects at a time
Ability to communicate [verbal and written] and interact with a team.
Training or Education required for this Position:
Minimum of a B.S. Degree in Engineering [mechanical, industrial, process, manufacturing or a related engineering field].
1+ years of experience in a manufacturing environment and demonstrated working knowledge of compliance, quality and scientific principles.
Include cover letter with resume.
- Location: Vancouver, WA
- Principals only. Recruiters, please don't contact this job poster.
- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.